BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1821923 · Received August 31, 2010

    Report

    Report Number
    1423500-2010-03040
    Event Type
    Injury
    Date Received
    August 31, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 11, 2010
    Manufacturer
    UNKNOWN MANUFACTURING FACILITY
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE LOT NUMBER WAS UNKNOWN, A BATCH REVIEW WAS NOT PERFORMED. ROOT CAUSE FOR THE PERITONITIS WAS NOT IDENTIFIED DUE TO INSUFFICIENT INFORMATION AVAILABLE. SINCE NO SAMPLE WAS AVAILABLE FOR EVALUATION, THE ROOT CAUSE CANNOT BE DETERMINED THROUGH SAMPLE INSPECTION. BAXTER HAS RECEIVED SIMILAR REPORTS AND WILL CONTINUE TO MONITOR THESE REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN. AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CONSUMER REPORT FROM THE (B)(6) REGARDING PERITONITIS IN A (B)(6) MALE HOMECHOICE PERITONEAL DIALYSIS (PD). ON (B)(6) 2010, THE PATIENT DEVELOPED PERITONITIS, MANIFESTED BY ABDOMINAL PAIN AND VOMITING AND WAS HOSPITALIZED THE SAME DAY. ON (B)(6) 2010, PRIOR TO THE START OF ANTIBIOTICS, A PERITONEAL EFFLUENT ANALYSIS WITH CULTURE AND GRAM STAIN WERE PERFORMED. AT THE TIME OF THIS REPORT, THE RESULTS OF THESE TESTS WERE PENDING. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH CIPROFLOXACIN 200 MG INTRAVENOUSLY (IV) EVERY 12 HOURS AND CEFUROXIME 750 MG IV EVERY EIGHT HOURS. THE EVENT OF PERITONITIS WAS ONGOING AND IMPROVED. PD THERAPY WAS ONGOING. THE REPORTER DID NOT PROVIDE AN OPINION OF CAUSALITY FOR THE EVENTS OF VOMITING AND PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENAL - DISPOSABLE SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ UNKNOWN MANUFACTURING FACILITY

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Hospitalization| R RANITIDINE, EPOGEN, TRAMADOL, METOCLOPROMIDE AND A